Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy

NCT03328351 | Completed DMC

• 1 other identifier: Dammam University
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

Background \& Purpose: Cervical radiculopathy is a neurological disorder, which commonly results because of nerve compression. There are different types of physical therapy interventions that are used for cervical radiculopathy. The evidence of effectiveness of manual therapy in cervical radiculopathy is still limited. Short-term hypoalgesic effects after manual therapy was found in different musculoskeletal conditions. However, the effectiveness of manual therapy in patients with cervical radiculopathy hasn't been investigated yet. Therefore, the aim of study is to examine the short-term effect of manual therapy (mobilization) on the sensory features in patients with chronic cervical radiculopathy.

Conditions

Cervical Radiculopathy

Keywords

Manual therapy; cervical radiculopathy; pressure pain threshold; physiotherapy

Outcome Measures

Primary Outcomes (2)

• pressure pain threshold (PPT)

  An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).

  Change from baseline in PPT at immediate post intervention

• pressure pain threshold (PPT)

  An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).

  Change from baseline in PPT at 3 weeks post intervention

Secondary Outcomes (8)

• Warmth/cold detection threshold and heat/cold pain threshold

  Change from baseline in thermal detection & pain threshold at immediate post intervention

• Warmth/cold detection threshold and heat/cold pain threshold

  Change from baseline in thermal detection & pain threshold at 3 weeks post intervention

• The Neck Disability Index (NDI)

  Change from baseline in NDI at immediate post intervention

• The Neck Disability Index (NDI)

  Change from baseline in NDI at 3 weeks post intervention

• Active Cervical Range of Motion

  Change from baseline in CROM at immediate post intervention

Study Arms (2)

manual group

EXPERIMENTAL

1. The Manual therapy (Mobilization): 1. Cervical postero-anterior vertebral mobilization glides: the mobilization was grade 3 for 2 min 3 set 2. Cervical lateral vertebral glides: the mobilization was grade 3 for 1 min 3 set. 2. Strengthening Exercises for deep neck flexor muscle

Other: manual therapy

sham group

SHAM COMPARATOR

1. Superficial soft tissue massage 2. Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times .

Other: Superficial soft tissue massage

Interventions

manual therapy OTHER

1. Manual therapy: One of the following techniques was used for the treatment group based on the patients' response (i.e centralization and reduction of symptoms). 1. Cervical postero-anterior vertebral mobilization glides: a central posteranterior (PA) or unilateral PA oscillatory pressure of grade III on the patient's most symptomatic level for 2 minute and 3 sets . 2. Cervical lateral vertebral glides :at grade III for 1 minute and 3 sets. 2. Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times.

Also known as: mobilization, deep neck flexor exercise

manual group

Superficial soft tissue massage OTHER

1\. Superficial soft tissue massage: The researcher applied a superficial effleurage massage without moving the deeper tissue for 2 minutes for 3 sets Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times

Also known as: deep neck flexor exercise

sham group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral neck pain and radiating to upper extremity \> 3 months.
• age :between 35 to 65 years old.
• Presence 3 out of 4 positive findings:
• spurling test.
• distraction test,
• upper limb neurodynamic test for median nerve
• ipsilateral cervical rotation test less than 60 degrees.

You may not qualify if:

• osteoporosis.
• tumor.
• metabolic disease (DM,resting blood pressure are greater than 140/90).
• rheumatoid arthritis.
• history of whiplash injury.
• myelopathy.
• pregnancy.
• history of cervical or thoracic surgery
• generalized neurological disorders .
• leg surgery or disease (fracture) -

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (2)

East jeddah general hospital

Jeddah, Saudi Arabia

Location

king Abdulaziz hospital

Jeddah, Saudi Arabia

Location

Related Publications (1)

• Alshami AM, Bamhair DA. Effect of manual therapy with exercise in patients with chronic cervical radiculopathy: a randomized clinical trial. Trials. 2021 Oct 18;22(1):716. doi: 10.1186/s13063-021-05690-y.

  PMID: 34663421 DERIVED

MeSH Terms

Conditions

Radiculopathy

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ali M Alshami, PHD

  Imam Abdulrahman Bin Faisal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: triple-blind (The researcher was blinded to the outcome measures, whereas the assessor, who performed the outcome measures was blinded to the patient groups. The patient was blinded to treatment)

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: November 1, 2017
• Study Start: December 18, 2016
• Primary Completion: August 24, 2017
• Study Completion: August 24, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)